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Multicomponent Exercise and Postural Hygiene

2. Juni 2026 aktualisiert von: Carmen Daniela Quero Calero, Catholic University of Murcia

Effects of a Postural Hygiene-Based Physical Exercise Program in Older Adult Women

This non-randomized clinical study aims to evaluate whether a multicomponent physical exercise program with integrated postural hygiene can improve functional capacity, postural risk, musculoskeletal symptoms, health-related quality of life, and body composition in adult and older women. Eighty participants are allocated to three groups: an experimental group performing exercise with integrated postural hygiene, a reference group with previous postural hygiene training performing the same intervention, and a control group performing the same exercise program without the postural hygiene component. Participants are assessed before, during, and after the intervention, as well as at follow-up. The broader research project also includes a separate cross-sectional observational component designed to describe postural habits, musculoskeletal symptoms, and functional health-related variables in women enrolled in a community-based Maintenance Gymnastics program.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The primary component is a non-randomized interventional study with parallel assignment designed to evaluate the effects of a multicomponent physical exercise program integrating postural hygiene strategies. The study is being registered after participant enrollment had started due to an administrative oversight. Data collection is ongoing and has not yet been completed. The intervention protocol, assessment schedule, and outcome measures were defined before completion of data collection and have not been modified based on study findings.

The interventional component includes 80 adult and older women allocated to three groups. The experimental group performs a multicomponent physical exercise program with integrated postural hygiene. The reference group consists of participants who had previously received postural hygiene training and performs the same intervention as the experimental group. The control group performs the same multicomponent physical exercise program without the specific postural hygiene component.

The intervention includes exercises targeting strength, balance, mobility, and postural control. Postural hygiene strategies are integrated throughout exercise practice and are intended to facilitate the transfer of healthy postural behaviors to activities of daily living. These strategies aim to improve postural awareness, movement control, and safer postural habits during functional tasks.

Participants are assessed at four time points: baseline, mid-intervention, post-intervention, and follow-up. Outcomes include functional capacity, postural risk, musculoskeletal symptoms, health-related quality of life, and body composition. Semi-structured interviews are also conducted to explore perceived changes, program acceptability, postural awareness, and the application of postural hygiene strategies in daily life.

The study is non-pharmacological, non-surgical, and non-invasive. It does not involve drug administration, surgical procedures, invasive techniques, or investigational medical devices. The intervention is delivered by trained instructors following a standardized protocol to ensure consistency across groups.

In addition to the interventional component, the broader project includes a separate cross-sectional observational epidemiological study conducted in a larger sample of women enrolled in the Maintenance Gymnastics program. This component is based exclusively on questionnaire data and aims to describe postural habits, musculoskeletal symptoms, body perception, and variables related to functional health in the target population. It does not include any intervention, group allocation, or follow-up assessments.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
    • Zaragoza
      • Zaragoza, Zaragoza, Spanien, 50009
        • Centro Deportivo Municipal Gran Vía

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

Inclusion Criteria:

  • Women enrolled in the Maintenance Gymnastics program
  • Age between 50 and 82 years.
  • Acceptance of participation in the study.

Exclusion Criteria:

  • Having diseases or conditions that prevent the proper performance of the activity and the assessments.
  • Having functional limitations that prevent safe participation in physical activity.
  • Having cognitive impairments that hinder understanding of instructions, tests, or questionnaires.
  • Refusal to participate in the study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Multicomponent physical exercise with integrated postural hygiene and no prior knowledge
Participants without prior postural hygiene knowledge will perform a structured multicomponent physical exercise program with integrated postural hygiene strategies. Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
Verhalten: Multicomponent physical exercise with integrated postural hygiene
Structured multicomponent physical exercise program including strength, balance, mobility, and postural control exercises, with integrated postural hygiene strategies during exercise execution and activities of daily living. Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors. This intervention will be assigned to the two arms with integrated postural hygiene.
Andere Namen:
  • Multicomponent exercise with strength, balance, mobility and postural control, integrating postural hygiene during exercise and daily activities under an instructor-controlled common protocol.
Sonstiges: Multicomponent physical exercise with integrated postural hygiene and prior knowledge
Participants with prior postural hygiene knowledge will perform the same structured multicomponent physical exercise program with integrated postural hygiene strategies as the experimental group. Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
Verhalten: Multicomponent physical exercise with integrated postural hygiene
Structured multicomponent physical exercise program including strength, balance, mobility, and postural control exercises, with integrated postural hygiene strategies during exercise execution and activities of daily living. Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors. This intervention will be assigned to the two arms with integrated postural hygiene.
Andere Namen:
  • Multicomponent exercise with strength, balance, mobility and postural control, integrating postural hygiene during exercise and daily activities under an instructor-controlled common protocol.
Aktiver Komparator: Multicomponent physical exercise without postural control
Participants will perform a structured multicomponent physical exercise program including strength, balance, and mobility exercises, but without the specific postural control component. Sessions will follow a previously established common protocol, with the same assessment procedures and time points as the other groups.
Verhalten: Multicomponent physical exercise without postural control
Structured multicomponent physical exercise program including strength, balance, and mobility exercises, delivered without the specific postural control component. Sessions will be conducted in the usual practice context, following a previously established common protocol and with implementation control by program instructors. This intervention will be assigned to the active comparator arm without postural control.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Functional Mobility Assessed Using the Timed Up and Go
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
The Timed Up and Go (TUG) test assesses functional mobility by measuring the time required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Lower values indicate better functional mobility and balance. Unit of Measure: seconds
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Change in Physical Performance Assessed Using the Short Physical Performance Battery
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
The Short Physical Performance Battery (SPPB) assesses physical performance using three standardized components: standing balance, usual gait speed, and the chair stand test. The balance assessment includes side-by-side, semi-tandem, and tandem standing positions. Gait speed is evaluated over a short walking distance, and lower-extremity functional strength is assessed using the repeated chair stand test. Each component is scored from 0 to 4 points, and the total score ranges from 0 to 12 points, with higher scores indicating better physical performance. Unit of Measure: Points
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Change in Postural Risk Assessed Using the Rapid Entire Body Assessment
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
The Rapid Entire Body Assessment (REBA) is an observational ergonomic assessment tool used to evaluate postural risk during functional tasks and movements. The assessment considers body posture, force/load handling, coupling, and activity level by examining the position of the neck, trunk, legs, upper arms, lower arms, and wrists. Total scores range from 1 to 15 points, with higher scores indicating greater postural and musculoskeletal risk and lower scores indicating lower postural risk. Unit of Measure: Points
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Musculoskeletal Symptoms Assessed Using the Nordic Musculoskeletal Questionnaire
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
The Nordic Musculoskeletal Questionnaire (NMQ) is a standardized questionnaire used to assess the presence and anatomical distribution of musculoskeletal symptoms across body regions, including the neck, shoulders, upper back, lower back, elbows, wrists/hands, hips/thighs, knees, and ankles/feet. The questionnaire records the presence or absence of pain, discomfort, or musculoskeletal symptoms during specified time periods. Results are reported separately for each body region, with a lower prevalence of symptoms indicating a better outcome. Unit of Measure: Presence or absence of musculoskeletal symptoms by body region.
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Change in Health-Related Quality of Life Assessed Using the SF-36 Questionnaire
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
The 36-Item Short Form Health Survey (SF-36) is a standardized questionnaire used to assess health-related quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed to a scale ranging from 0 to 100 points, with higher scores indicating better perceived health status and quality of life. Unit of Measure: Points
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Change in Body Composition Assessed Using the TANITA BC-401 Monitor
Zeitfenster: Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Body composition will be assessed using the TANITA BC-401 body composition monitor. The following parameters will be recorded: body weight (kg), body fat percentage (%), muscle mass (kg), visceral fat (rating), total body water (%), bone mass (kg), and body mass index (kg/m²). Higher muscle mass and total body water values, together with lower body fat percentage, visceral fat and BMI values, indicate improved body composition outcomes following the intervention.
Baseline, mid-intervention (4.5 months), post-intervention (9 months), and 6 months after completion of the intervention (15 months from baseline)
Postural Awareness Scale
Zeitfenster: Baseline
The Postural Awareness Scale (PAS) is a self-report questionnaire designed to assess an individual's awareness of body posture, body alignment, and postural sensations during daily activities. The scale evaluates conscious perception of body position, muscular tension, and postural adjustments. Higher scores indicate greater postural awareness and improved perception of body posture and movement. Unit of Measure: points
Baseline
Back Pain and Body Posture Questionnaire
Zeitfenster: Baseline
The Back Pain and Body Posture Evaluation Instrument for Adults (BackPEI-A) is a self-administered questionnaire designed to assess back pain prevalence, postural habits, ergonomic behaviors, and lifestyle-related factors associated with spinal health in adults. The questionnaire includes items related to pain frequency and intensity, sitting posture, sleeping posture, backpack or load carrying habits, physical activity, and daily postural behaviors. Higher frequencies of inappropriate postural habits and back pain symptoms indicate poorer spinal health and postural behavior outcomes. Unit of Measure: categorical responses and frequency scores
Baseline

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Perceived Changes, Acceptability, and Transfer of Postural Hygiene Strategies
Zeitfenster: Post-intervention.
Perceived changes following the intervention, intervention acceptability, barriers and facilitators to adherence, body awareness, and transfer of postural hygiene strategies to activities of daily living will be explored through semi-structured interviews conducted with participants from the study groups. Qualitative data will be analyzed using thematic content analysis to identify common themes and experiences related to the intervention. Unit of Measure: qualitative thematic categories
Post-intervention.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Catholic University of Murcia

Ermittler

  • Hauptermittler: Ana I. Rodrigo, Catholic University of Murcia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Juni 2025

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

30. September 2026

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Juni 2026

Zuerst gepostet (Tatsächlich)

8. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CE092506

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

The raw data supporting the conclusions of this intervention will be made available by the investigators, without undule reservación, to and qualified researcher.

IPD-Sharing-Zeitrahmen

Data will be available upon reasonable request after publication of the main study results and for a period consistent with applicable ethical and data protection requirements.

IPD-Sharing-Zugriffskriterien

De-identified individual participant data may be made available to qualified researchers upon reasonable request for scientific purposes related to this study. Requests will be reviewed by the research team and, when applicable, by the responsible institution. Access will only be granted after approval of the request and in accordance with applicable ethical requirements and data protection regulations.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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